(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was not returned for evaluation.A review of the lot history record was not performed because the lot number was not reported and the product was not returned for analysis.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.The reported patient effects of angina and thrombosis are listed in the xience alpine, everolimus eluting coronary stent systems instructions for use as a known patient effects of coronary stenting procedures.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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It was reported that the procedure was to treat a lesion in the left anterior descending coronary artery.On (b)(6) 2018, the 3.25x23mm xience alpine was implanted.The patient was compliant with the antiplatelet drug.On (b)(6) 2018, the patient returned with chest pain, angiography was performed and in-stent thrombosis of the implanted xience alpine stent was confirmed.The patient was treated with an unspecified balloon dilatation catheter.On an unspecified date, the patient failed a stress test, thus on (b)(6) 2018, the patient was brought back for re-catheterization.The xience alpine was confirmed to have remained patent.The patient is stable.There was no adverse patient sequelae.No additional information was provided.
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